GMP Documentation Specialist
3 settimane fa
Description
Job Title: GMP Documentation Specialist
Location: Pisa
- Ensure GMP compliance through effective management of production documentation, including critical revision, approval, issuance, and maintenance.
- Develop and execute training programs on production documentation, focusing on strong training efficacy.
- Manage logistics for manufacturing and visual inspection, including preparation and distribution of documentation.
- Identify and address gaps in manufacturing and visual inspection processes.
- Collaborate with regulatory authorities during audits.
- Guarantee data management for trending purposes.
- Manage direct reports involved in production documentation, logistics, deviation management, and process optimization.
- Develop and implement strategies to meet production objectives and ensure compliance.
- Foster a culture of quality and compliance within the team.
- Ensure the security of production documentation and facilities.
Requirements
- Degree in scientific disciplines (Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- At least 5 years of experience in pharmaceutical companies, with deep knowledge of aseptic production processes.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
- Good knowledge of English and main IT applications (Word, Excel, PowerPoint). Previous use of Trackwise System.
- Familiarity with digitalization of systems and processes.
- Strong relationship and communication skills, ability to influence others.
- Ability to take independent decisions based on data evaluation and risk assessment.
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